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10.10.12.00.htm 10.10.12.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 10 LABORATORIES Chapter 12 Medical Laboratories ― Public Health HIV Testing Programs Authority: Health-General Article, Annotated Code of MarylandRegulation. Sections. 01 Scope. 17-202. 02 Definitions. 03 Incorporation by Reference. 17-201, 17-202. 04 Public Health Testing License, for Rapid HIV Antibody Testing. 17-202, 17-204, 17-205, 17-206, 17-207, 17-208, 17-209, 17-210.
10.10.12.01.htm 10.10.12.01. 01 Scope.. A. This chapter sets the standards and requirements for a person to obtain and maintain a public health testing license to operate a public health testing program to perform rapid HIV antibody testing and rapid hepatitis C virus testing.B. This chapter applies to public health testing programs approved by the Secretary to conduct rapid HIV antibody testing and rapid hepatitis C virus testing.
10.10.12.02.htm 10.10.12.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "CDC" means the federal Centers for Disease Control and Prevention.. 2) "CLIA" means the federal Clinical Laboratory Improvement Amendments of 1988.. 3) "Department" means the Department of Health and Mental Hygiene.. 4) "Primary standard" means a general comprehensive standard or set of standards as defined in COMAR 10.10.01.03B.5) "Public health testing
10.10.12.03.htm 10.10.12.03. 03 Incorporation by Reference.. In this chapter, the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988 (2007) is incorporated by reference.
10.10.12.04.htm 10.10.12.04. 04 Public Health Testing License for Rapid HIV Antibody Testing and HCV Testing.. A. A person shall obtain a public health testing license before offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing.B. A person may not:. 1) Offer or perform rapid HIV antibody testing or hepatitis C virus testing without obtaining a public health testing license issued under this chapter; or2) Transfer the public health testing license to another person..
10.10.12.05.htm 10.10.12.05. 05 Quality Assessment Plan and Quality Control Requirements.. A. Primary Standard. A person seeking or holding a public health testing license shall establish and maintain a quality assessment plan with written policies and procedures for monitoring and evaluating the operations and activities of the program.B. Quality Assessment Plan Components. A person seeking or holding a public health testing license shall ensure that the quality assessment plan addresses the operations and a
10.10.12.06.htm 10.10.12.06. 06 Personnel Training and Competency.. A. Primary Standard. A person seeking or holding a public health testing license shall ensure that the personnel of the public health testing program are trained in how to perform assigned tasks and responsibilities.B. Personnel Training Components. A person seeking or holding a public health testing license shall ensure that personnel training includes the following components:
10.10.12.07.htm 10.10.12.07. 07 Standard Operating Procedures Manual.. A. Primary Standard. A person seeking or holding a public health testing license shall develop and maintain a standard operating procedures manual (SOPM) that is available to and followed by the public health testing program personnel.B. A person seeking or holding a public health testing license shall ensure that the SOPM includes the step-by-step instructions for the operations, tasks, and techniques occurring before, during, and
10.10.12.08.htm 10.10.12.08. 08 Public Health Testing Program Director.. A. Primary Standard. A person seeking or holding a public health testing license shall employ or otherwise engage the services of a director to oversee and manage the public health testing program.B. The director of a public health testing program shall oversee the planning, organization, direction, operation, and review of the program's operations, including:1) Recruiting competent personnel;.
10.10.12.09.htm 10.10.12.09. 09 Manufacturer's Requirements.. A. Primary Standard. In addition to meeting the quality assessment plan requirements set forth in Regulation .05 of this chapter, a person seeking or holding a public health testing license shall ensure that public health testing program personnel meet the requirements and follow the manufacturer's test specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used.B. A person seeking or holding a public health tes
10.10.12.10.htm 10.10.12.10. 10 Confirmatory Test.. When an individual has a positive test result with the rapid HIV antibody test or rapid hepatitis C virus test, a person seeking or holding a public health testing license to offer or perform testing shall:A. Offer to perform a confirmatory test;. B. Collect a specimen to refer to a laboratory to perform a confirmatory test; or. C. Refer that individual to a health care provider to have a confirmatory test performed..
10.10.12.9999.htm 10.10.12.9999. Administrative History Effective date:. Regulations .01―10 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287) adopted permanently effective March 14, 2005 (32:5 Md. R. 580)Regulation .01A, B amended effective April 1, 2013 (40:6 Md. R. 473). Regulation .02B amended effective April 1, 2013 (40:6 Md. R. 473). Regulation .03 amended effective April 1, 2013 (40:6 Md. R. 473). Regulation .04 amended effective April 1, 2013 (40:6 Md. R. 473).
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